Nasopharyngeal Carcinoma
Conditions
Interventions
Experimental group:The patient received tislelizumab 200mg on day 1, Q3W for two cycles of induction therapy, followed by hyperfractionated radiotherapy. The radiotherapy doses were: 52.5Gy for PGTVnx
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-75 years old, gender not limited; 2) Histologically confirmed nasopharyngeal carcinoma, non-keratinized undifferentiated type; 3) AJCC version 9 stage T1-2N0 (IA stage) and GTVnx volume = 3.0×10^9/L, ANC>= 2.0×10^9/L, PLT>= 100×10^9/L, HGB>= 90g/L (no blood transfusion or blood products within 14 days, and no correction using G-CSF or other hematopoietic stimulating factors) (2) Biochemical tests should meet the following standards: TBIL= 60ml/min (Cockcroft-Gault formula); (3) Good coagulation function: Defined as an international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; If the subject is undergoing anticoagulant therapy, it is acceptable as long as the PT is within the prescribed range of anticoagulant drugs. (4) The myocardial enzyme spectrum is within the normal range. 10) Women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment with a negative result, and be willing to use effective contraceptive methods during the treatment period and for the following 2 months. For male subjects whose partners are women of childbearing age, effective contraceptive methods should be adopted during the treatment period and for two months thereafter. 11) The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1) Pre-existing or concurrent malignant tumors in other parts that have not been cured, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, papillary thyroid carcinoma and superficial bladder cancer; 2) Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy returns to normal); Patients with vitiligo or those whose childhood asthma has been completely relieved and do not require any intervention in adulthood can be included. However, asthma patients who need medical intervention with bronchodilators cannot be included. 3) Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >= 470 ms); According to the NYHA standard, patients with grade ? to ? cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography; Myocardial infarction occurred within one year; 4) There is an active infection or an unexplained fever > 38.5°C during the screening period or before the first administration (as determined by the researcher, the subjects with fever caused by tumors can be enrolled); 5) Suffering from congenital or acquired immune deficiency (such as HIV-infected individuals), active hepatitis B (HBV-DNA>= 104 copies /ml), or hepatitis C (hepatitis C antibody positive, and HCR-RNA higher than the detection limit of the analytical method); 6) Has previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1; 7) Known to be allergic to cisplatin, large molecule protein preparations, or any anti-PD-1 antibody component; 8) If the subject undergoes major surgery for non-tumor treatment, the toxic reactions and/or complications caused by the surgical intervention must be fully recovered before the treatment commences. 9) Pregnant or lactating women; 10) If the researcher determines that the subject has other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, having severely abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month CR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year PFS rate;OS;2-year LC rate;2-year RC rate;2-year DMFS rate;Safety; | — |
Countries
China
Contacts
Public ContactJunlin Yi
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed